Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension
Status and phase
Completed
Phase 4
Conditions
Hypertension
Treatments
Drug: amlodipine
Drug: Valsartan/HCTZ
Drug: HCTZ
Details and patient eligibility
About
This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood pressure monitoring (ABPM)
Enrollment
480 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female patients 18 years of age or older
- Diagnosed of having hypertension, defined as a mean seated systolic BP ≥160 mmHg (Stage 2 hypertension)
Exclusion criteria
- Symptomatic or severe hypertension
- Patients treated with more than 2 antihypertensive medications
- Clinically known or suspected history of secondary hypertension
- Myocardial infarction, stroke, transient ischemic attack, cardiovascular revascularization/angioplasty in last 6 months
- Diagnosis of heart failure (NYHA Class II-IV)
- Chronic renal or severe hepatic disease
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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